In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Patients with de novo lesions in native coronary arteries that meet the eligibility criteria and
sign the informed consent form will participate in this study.
The observed event rate for the primary endpoints is assumed to be 2% at 12
months so a sample size of 200 subjects will provide a 95% confidence interval [0.5%, 5%]. It is expected that the lost to follow-up rate at 12 months is less than 10%; however, a total of 230 patients will be conservatively enrolled in this trial to ensure that at least 200 patients will be evaluable at 12 months.
Centers (n≈30) are allowed to enroll a maximum of 40 subjects per center or until study enrollment has been completed, whichever comes first.
The primary endpoint for all patients enrolled in this study is the composite rate
Frequency of Follow-up Assessments: 30 days, 6 months,
12 months, and 24 months post-procedure.
The patient must return to the site where the procedure was performed for a clinic visit and 12-lead ECG at 12 months. The expected length of time for enrollment is approximately 12 months. The study will be conducted for a minimum of two (2) years from enrollment of the final subject.
Final Study Results
Actual Number of Patients Enrolled
Actual Number of Sites Enrolled
Thirty sites enrolled in the study; however, one site did not enroll any study subjects
and was subsequently closed.
Patient Followup Rate
Final Safety Findings
Primary endpoint: Cardiac death (CD) and target vessel myocardial infarction (TVMI) at 12 months: 3.5%
(8/226, 95% CI: 1.5%-6.9%). It was expected that the composite rate of CD/TVMI will be consistent with the rate observed in the Resolute-US pre-approval trial (2% [95% CI: 0.5% - 5%]). The rate in this PAS does not seem to be much different. However, this PAS was designed to provide certain precision around the primary endpoint rate and not to test for differences in the studies¿ rates.
Secondary endpoints at 24 months:
Cardiac Death and Target Vessel Myocardial Infarction: 5.9% (13/219)
residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method.
2 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using the assigned device only.
7 The attainment of < 30% residual stenosis by QCA (or < 20% by visual assessment) AND TIMI flow 3 after the procedure, using any percutaneous method without the occurrence of MACE during the hospital stay.
Study Strengths and Weaknesses
This study provides longer term (2 years) safety and effectiveness results of the Resolute Zotarolimus-
Eluting Coronary Stent System. This post-approval study was conducted in the United States and had a very low lost to follow-up rate. This study confirmed the safety and effectiveness results of the premarket data on the Resolute Zotarolimus-Eluting Coronary Stent System.
Recommendations for Labeling Changes
A labeling change is recommended to add a summary of the post-approval study results including
study strengths and limitations. The updated label will reflect the long-term (2-years) postmarket performance of the device.